Raza Alikhan , May Nour , Masahiro Yasaka , Richard Ofori-Asenso , Stina Axelsson-Chéramy , Hungta Chen , Vinay Seghal , Shoji Yokobori , Bruce Koch , Andreas Tiede , Brooks D. Cash , Marc Maegele , Adam J. Singer
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The primary objectives of the REVERXaL study are to describe patient characteristics, health care interventions during the acute-care phase, in-hospital outcomes, and associations between timing of reversal/replacement agent administration and in-hospital outcomes. Secondary/exploratory objectives focus on clinical assessments and patient-reported outcome measures (PROMs) at 30 and 90 days.</p></div><div><h3>Methods</h3><p>REVERXaL is a multinational, observational study of hospitalized patients with FXai-associated major bleeds in Germany, Japan, the United Kingdom, and the United States. The study includes 2 cohorts of approximately 2000 patients each. Cohort A is a historic cohort for whom medical chart data will be collected from hospitalization to discharge for patients admitted for major bleeds during FXai use within 2 years prior to enrollment of Cohort B. Cohort B will prospectively enroll patients administered any reversal/replacement agent during hospitalization to manage FXai-associated major bleeds and will include the collection of clinical outcomes and PROMs data over 3 months.</p></div><div><h3>Conclusions</h3><p>REVERXaL will generate insights on patient characteristics, treatment approaches, and associated outcomes in patients hospitalized with FXai-associated major bleeds. These data may inform clinical practice and streamline treatment pathways in this population.</p></div><div><h3>Registration</h3><p>URL: <span>https://www.clinicaltrials.gov</span><svg><path></path></svg>; unique identifier: <span>NCT06147830</span><svg><path></path></svg>.</p></div>","PeriodicalId":23064,"journal":{"name":"Thrombosis research","volume":null,"pages":null},"PeriodicalIF":3.7000,"publicationDate":"2024-06-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S0049384824001786/pdfft?md5=bc3126895df368049ef616f876aa0e12&pid=1-s2.0-S0049384824001786-main.pdf","citationCount":"0","resultStr":"{\"title\":\"Design and rationale for REVERXaL: A real-world study of patients with factor Xa inhibitor–associated major bleeds\",\"authors\":\"Raza Alikhan , May Nour , Masahiro Yasaka , Richard Ofori-Asenso , Stina Axelsson-Chéramy , Hungta Chen , Vinay Seghal , Shoji Yokobori , Bruce Koch , Andreas Tiede , Brooks D. 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引用次数: 0
摘要
背景随着全球人口老龄化,心血管并发症的负担越来越重,抗凝治疗的普及率也在不断上升。包括 Xa 因子抑制剂(FXai)在内的直接口服抗凝剂正在取代维生素 K 拮抗剂,成为降低血栓事件风险的最常用处方药。虽然与 FXai 相关的自发性出血风险已经确定,但人们对其管理以及治疗对临床和患者报告结果的影响了解较少。REVERXaL研究的主要目标是描述患者特征、急诊阶段的医疗干预、院内预后以及逆转/替代药物给药时机与院内预后之间的关系。REVERXaL是一项跨国观察性研究,对象是德国、日本、英国和美国的福赛相关大出血住院患者。该研究包括两个队列,每个队列约有 2000 名患者。队列 A 是一个历史队列,将收集队列 B 入选前 2 年内因使用 FXai 期间发生大出血而入院的患者从住院到出院的病历数据。队列 B 将前瞻性地招募住院期间使用任何逆转/替代药物治疗 FXai 相关大出血的患者,并将收集 3 个月内的临床结果和 PROMs 数据。这些数据可为临床实践提供参考,并简化该人群的治疗路径。注册网址:https://www.clinicaltrials.gov;唯一标识符:NCT06147830。
Design and rationale for REVERXaL: A real-world study of patients with factor Xa inhibitor–associated major bleeds
Background
The prevalence of anticoagulation treatment is increasing as an aging global population faces a high burden of cardiovascular comorbidities. Direct oral anticoagulants, including factor Xa inhibitors (FXai), are replacing vitamin K antagonists as the most commonly prescribed treatment for reducing risk of thrombotic events. While the risk of FXai-associated spontaneous bleeds is established, less is understood about their management and the effect of treatment on clinical and patient-reported outcomes. The primary objectives of the REVERXaL study are to describe patient characteristics, health care interventions during the acute-care phase, in-hospital outcomes, and associations between timing of reversal/replacement agent administration and in-hospital outcomes. Secondary/exploratory objectives focus on clinical assessments and patient-reported outcome measures (PROMs) at 30 and 90 days.
Methods
REVERXaL is a multinational, observational study of hospitalized patients with FXai-associated major bleeds in Germany, Japan, the United Kingdom, and the United States. The study includes 2 cohorts of approximately 2000 patients each. Cohort A is a historic cohort for whom medical chart data will be collected from hospitalization to discharge for patients admitted for major bleeds during FXai use within 2 years prior to enrollment of Cohort B. Cohort B will prospectively enroll patients administered any reversal/replacement agent during hospitalization to manage FXai-associated major bleeds and will include the collection of clinical outcomes and PROMs data over 3 months.
Conclusions
REVERXaL will generate insights on patient characteristics, treatment approaches, and associated outcomes in patients hospitalized with FXai-associated major bleeds. These data may inform clinical practice and streamline treatment pathways in this population.
期刊介绍:
Thrombosis Research is an international journal dedicated to the swift dissemination of new information on thrombosis, hemostasis, and vascular biology, aimed at advancing both science and clinical care. The journal publishes peer-reviewed original research, reviews, editorials, opinions, and critiques, covering both basic and clinical studies. Priority is given to research that promises novel approaches in the diagnosis, therapy, prognosis, and prevention of thrombotic and hemorrhagic diseases.